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Prospective Longitudinal Observational Research in Atopic Dermatitis (ProRaD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240522
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
University of Bonn
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

Atopic dermatitis (AD) is a frequent chronic relapsing inflammatory skin disorder, characterized by intensely itchy eczema. AD usually starts within the first 2 years of life. In 30 - 60% of children, inflammation spreads onto other body surfaces such as the gastrointestinal tract, the respiratory tract, and the conjunctives within a few years. This sequence is called atopic march.

Atopic dermatitis and associated atopic diseases are more frequent in families, suggesting a genetic predisposition. However, the underlying factors such as genetic phenotype, environmental factors, or life style which cause or worsen an existing allergic disease are not understood yet. Affected people suffer from recurrent flares that result in significantly impaired quality.

This study will collect clinical and laboratory data to elucidate immunotolerance and preventiv stategies with the aim to develop new and individual treatment options of atopic diseases.


Condition or disease
Https://Meshb.Nlm.Nih.Gov/Record/ui?ui=D003876 Atopic Dermatitis Asthma Atopic Dermatitis and Related Conditions

Detailed Description:

Primary Objetive:

In the planned project, the main objective is to identify endogenous (e.g. immunological and molecular factors) and exogenous factors (e.g. environmental, socioeconomic and microbial factors) that influence the course and remission of AD. More specifically to identify factors that are significantly different between patients that have or do not have remission from AD.

Secondary Objective:

(i) To identify endogenous and exogenous factors such as immunological, molecular and microbial factors to separate subgroups of patients (endotypes) with distinct local and systemic inflammatory responses.

(ii) To identify potential biomarkers predicting the individual clinical course of AD and other atopic diseases including asthma, food allergy and allergic rhinitis.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Longitudinal Observational Research Study to Investigate the Remission of Atopic Dermatitis and Associated Allergic Diseases
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : January 20, 2020
Estimated Study Completion Date : April 4, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema




Primary Outcome Measures :
  1. Remission of atopic dermatitis and associated allergic diseases [ Time Frame: 5 years ]
    Prospective observational study

  2. Endogenous and exgogenouse factors that influence and predict the cours of AD. [ Time Frame: 5 years ]
    SCORAD


Biospecimen Retention:   Samples With DNA
serum samples, Microbiom swabs Ski biopsy (selcted cases)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patietns with atopic dermatits, any other allergic diseases and /or healthy controls
Criteria

Inclusion Criteria:

-

The inclusion criteria for patients in this study are as follows:

  1. Age 0 - 85 years
  2. Diagnosis of AD and/or another disease of the atopic group (i.e. allergic rhinitis, allergic asthma, food allergy)
  3. The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated

The inclusion criteria for healthy controls in this study are as follows:

  1. Age 0 - 85 years
  2. No diagnosis or history of allergic disease
  3. The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated Written consent will be obtained after detailed information of the study was given to the participant.

Exclusion Criteria Unable to give consent or refusal to participate in the study

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240522


Locations
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Switzerland
Allergy Unit, Dept. of Dermatology, Unviersity Hosptial of Zurich Recruiting
Zürich, Switzerland, 8091
Contact: Peter Schmid-Grendelmeier, Prof, MD    +41442553079    peter.schmid@usz.ch   
Sponsors and Collaborators
University of Zurich
University of Bonn
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04240522    
Other Study ID Numbers: BASEC 2016-00301
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Eczema
Dermatitis
Atopy
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases